MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD

Model Number	RBY2C0435-B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil, pod detachment handle (handle) and, lantern delivery microcatheter (lantern).During the procedure, while inserting a ruby coil into lantern, the ruby coil unintentionally detached from the pusher assembly and became stuck at the distal tip of the microcatheter.Therefore, the physician used several injections of saline with a 3cc syringe to push the detached ruby coil into the vessel.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured at approximately 57.0 cm from the proximal end.The pusher assembly was kinked approximately 58.0 cm from the proximal end.The pull wire was retracted from the pusher assembly distal detachment tip (ddt) and the embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned lantern revealed a distal shaft ovalization.If the device is forcefully gripped or pinched during the procedure, damage such as an ovalization may occur.This ovalization likely contributed to the resistance experienced during the procedure.During functional testing, a demonstration ruby coil was unable to advance through the lantern due to the ovalization.Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly and revealed that the pusher assembly was kinked and fractured.It the ruby coil is forcefully advanced against resistance, damages such as pusher assembly kink and fracture may occur.The fractured pusher assembly likely resulted in the pull wire being retracted out of the ddt and the embolization coil detaching from its pusher assembly.The resistance was due to the distal ovalization on the returned lantern that was used in the procedure.Penumbra coils and catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2020-00944 h3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10176826
• Report Number: 3005168196-2020-00803
• Device Sequence Number: 2974128
• Product Code: HCG
• UDI-Device Identifier: 00814548018614
• UDI-Public: 00814548018614
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY2C0435-B
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F92164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005